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To print: Select File and then Print from your browser's menu Title: Pfizer Receives Approval on New Lipitor Starting Doses |
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"Pfizer Receives Approval on New Lipitor Starting Doses" Provides Physicians Additional Options to Individualize Cholesterol-Lowering Drug Therapy NEW YORK, NY -- April 29, 2002 -- Pfizer Inc said today that the U.S. Food and Drug Administration has approved new recommended starting doses for Lipitor® (atorvastatin calcium). This will allow physicians greater flexibility in treating the estimated 54 million Americans who are eligible for cholesterol-lowering drug therapy. Since its introduction in 1997, Lipitor has more than 36 million patient years of therapy and is the most widely prescribed cholesterol-lowering medication in the world. The recommended starting doses are 10 mg, 20 mg or 40 mg. The 40 mg dose is recommended for patients who require a reduction in LDL-cholesterol of more than 45 percent. As in the past, therapy for patients requiring further reductions can be adjusted up to the 80 mg dose. The safety profile and efficacy of Lipitor have been demonstrated in more than 400 ongoing and completed clinical trials involving over 80,000 patients. "Lipitor continues to provide physicians with proven efficacy and safety across the dose range by getting the vast majority of patients to their cholesterol goal levels," said Dr. Joseph Feczko, Pfizer's senior vice president for medical and regulatory operations. "There are significant health benefits for patients who maintain healthy cholesterol levels and the new recommended Lipitor starting doses allow physicians to address this critical need based on the patient's individual risk with fewer dose adjustments." In addition, the revised Lipitor labeling further supports the implementation of national cholesterol guidelines which call for early and intensive treatment in cholesterol management. Lipitor (atorvastatin calcium) tablets is a prescription drug used with diet to lower cholesterol. Lipitor is not for everyone, including those with liver disease or possible liver problems, women who are nursing, pregnant, or may become pregnant. Lipitor has not been shown to prevent heart disease or heart attacks. If you take Lipitor, tell your doctor about any unusual muscle pain or weakness. This could be a sign of serious side effects. It is important to tell your doctor about any medications you are currently taking to avoid possible serious drug interactions. Your doctor may do simple blood tests to monitor liver function before and during drug treatment. The most commonly reported side effects are gas, constipation, stomach pain and indigestion. They are usually mild and tend to go away. For full prescribing information or to receive free educational material about cholesterol visit |
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